Relationship-building isn’t always the first thing that comes to mind when talking about the clinical development industry. Concerns about bedside manner, accessible care, and onerous clinical trials are common, and often for good reason. Fortunately, the industry—and our people in particular—are working hard to fix that.
Making clinical research work for the patients who need it most is a great example of our first HI*PRA value: Human-Centricity. It requires teamwork and collaboration across all ends of the clinical development spectrum. This includes forming long-lasting partnerships with the drug developers who bring life-changing treatments to fruition.
PRA’s Clinical Sciences and Study Management (CSSM) team’s partnership with Merck shows how effective communication and trust can take clinical development to the next level.
The CSSM team is embedded at Merck and is responsible for the operational and scientific implementation of clinical trials. Comprising clinical scientists and study managers, the group provides medical expertise, contributes to key study documents, manages timelines, and addresses various study-specific questions and protocol issues that impact patient safety and clinical trial data. Senior Study Managers are responsible for leading the cross functional clinical trial team and collaborate with key stakeholders to manage program timelines. Senior Clinical Scientists lead the Medical Monitoring team to analyze data across a trial for trends. The CSSM team represents the PRA brand, partnering with Merck on a global scale to deliver effective, efficient, and life-improving clinical trials that ultimately may lead to safe and effective drugs for patients around the world.
Although PRA has worked with Merck in a variety of functions for over a decade, the relationship with CSSM wasn’t always what it is today. When Cindy Larkin, Senior Director of Clinical Operations within PRA’s Strategic Solutions Division (SSD), joined the Merck CSSM partnership in 2016, the CSSM team faced an uphill battle. PRA was the second vendor to come on board. Merck was initially resistant because of their established relationship with another vendor. The CSSM leadership team realized they needed to establish trust with Merck’s executive directors and program leads to build long-lasting relationships and ensure PRA meets or exceeds expectations.
The leadership team we have in place exhibits strong emotional intelligence, so for some, building trust comes by nature. We’ve also adopted the ‘woo’ approach—winning others over. It’s important that we help Merck understand we’re going to be right there with them throughout every step of the clinical development process.
Cindy Larkin, Sr Director of Clinical Operations
She shares that overcommunicating, overdelivering, and working collaboratively have all been key in building the trust that now exists within the PRA-Merck CSSM partnership.
Collaboration between PRA and Merck happens at all levels, from placing qualified individuals into the right roles to resolving performance-based issues. When a performance issue arises, the first action is collaboration between PRA CSSM and Merck leaders. Together, the two teams identify the root cause of the issue and then PRA establishes a plan of action to help the employee turn issues around and provide the support and training needed to continue to contribute to the team.
When larger challenges arise, vulnerability makes all the difference.
I’ve learned that becoming vulnerable and non-defensive in the face of conflict goes a long way. Sharing your personal story of where you are in that relationship and having those crucial, difficult conversations is critical in fostering long-lasting partnerships built on mutual respect and trust.
Cindy Larkin, Sr Director of Clinical Operations
This approach seems to be shared by members across the CSSM team as well as at Merck, and PRA has partnered with Merck on various talent development strategies to support ongoing career development and to foster in-role learning.
Building long-lasting, trusting relationships is just as meaningful internally as it is externally. The 170 individuals within CSSM are fully embedded into the Merck teams. Their day-to-day usually consists of working closely with Merck’s full-time employees (FTEs) and other vendors rather than a lot of cross-collaboration only within the PRA CSSM team. This structure could very easily lead to a divide or lack of communication amongst the team. Fortunately, the CSSM team’s management recognized this risk early on and put in place measures to ensure the team operates as a single, cohesive group.
One example is a formal mentorship program. New employees are assigned a mentor as soon as they join the team. Mentors help guide new employees through both PRA and Merck's cultures, as the CSSM team members must navigate both simultaneously. These one-on-one mentorships provide an intimate way for new employees to not only become acquainted with the partnership, but establish trusted relationships with more senior team members.
I have had a good experience with my mentor. It was a very positive experience which helped me get acclimated faster to my role. I scheduled weekly calls with my mentor and brought questions to the table every time we met. I appreciate how my mentor helped me with navigating through JReview and with medical monitoring questions.
Maitri Patel, Clinical Research Scientist
Members of the CSSM team work independently and collaboratively to help Merck achieve their drug development goals. From writing protocol amendments and adding last-minute database locks to working long hours and leading conference calls around the world, the team moves with great flexibility and grace. They understand that at the end of the day, the work they’re doing could ultimately improve peoples’ lives. They’re dedicated to working cohesively with each other and with Merck to make sure that happens.
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